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FDA 510(k) Application Details - K220529
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K220529
Device Name
Wheelchair, Powered
Applicant
Merits Health Products Co., LTD.
No. 18, Jingke Rd., Nantun Dist.
Taichung 40852 TW
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Contact
Martin Tseng
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
02/24/2022
Decision Date
03/18/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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